CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

GE HEALTHCARE FINLAND OY

The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape Respiratory Modules, E-sco, E-scov, E-scovx, E-scaio, E-scaiov, E-scaiovx.

Pre-market Notification Details

Device IDK150245
510k NumberK150245
Device Name:CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki,  FI Fin-00510
ContactMari Salmenkaita
CorrespondentMari Salmenkaita
GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki,  FI Fin-00510
Product CodeCCK  
Subsequent Product CodeBZK
Subsequent Product CodeBZL
Subsequent Product CodeCAP
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCL
Subsequent Product CodeNHO
Subsequent Product CodeNHP
Subsequent Product CodeNHQ
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682104289 K150245 000
00840682104067 K150245 000
00840682104258 K150245 000
00840682104180 K150245 000
00840682104173 K150245 000
00840682104142 K150245 000
00840682102919 K150245 000
20840682102883 K150245 000

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